Increase the manufacturing efficiency of the assembled cassette by modifying the assembly method used in the manufacture of nmp22 bladderchek from assembled and pouched manually by hand by operators, to be assembled by validated automated equipment.
| Device | NMP22 BLADDERCHEK TEST |
| Classification Name | System, Test, Tumor Marker, For Detection Of Bladder Cancer |
| Generic Name | System, Test, Tumor Marker, For Detection Of Bladder Cancer |
| Applicant | ALERE SCARBOROUGH, INC |
| Date Received | 2013-03-18 |
| Decision Date | 2013-04-02 |
| PMA | P940035 |
| Supplement | S009 |
| Product Code | NAH |
| Advisory Committee | Immunology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ALERE SCARBOROUGH, INC 10 Southgate Road scarborough, ME 04074 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P940035 | | Original Filing |
| S017 |
2022-02-08 |
Normal 180 Day Track No User Fee |
| S016 |
2021-05-27 |
30-day Notice |
| S015 |
2018-04-18 |
30-day Notice |
| S014 |
2017-01-30 |
30-day Notice |
| S013 |
2016-08-16 |
30-day Notice |
| S012 |
2016-04-06 |
30-day Notice |
| S011 |
2015-07-01 |
30-day Notice |
| S010 |
2013-07-10 |
Special (immediate Track) |
| S009 |
2013-03-18 |
30-day Notice |
| S008 |
2010-11-22 |
Normal 180 Day Track No User Fee |
| S007 |
2011-07-27 |
Normal 180 Day Track No User Fee |
| S006 |
2011-05-11 |
Normal 180 Day Track No User Fee |
| S005 |
2008-05-16 |
Normal 180 Day Track No User Fee |
| S004 |
2008-03-27 |
Normal 180 Day Track No User Fee |
| S003 |
2002-09-16 |
Normal 180 Day Track |
| S002 |
1999-07-23 |
Panel Track |
| S001 |
1996-12-16 |
Normal 180 Day Track |
NIH GUDID Devices